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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 ASR UNI FEMORAL IMPL SIZE 47; HIP FEMORAL HEAD
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DEPUY INTERNATIONAL LTD. 8010379 ASR UNI FEMORAL IMPL SIZE 47; HIP FEMORAL HEAD Back to Search Results
Catalog Number 999890247
Device Problems Metal Shedding Debris (1804); Naturally Worn (2988); Insufficient Information (3190)
Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Pain (1994); Distress (2329); Injury (2348); Not Applicable (3189); No Code Available (3191)
Event Date 01/15/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Patient was revised to address pain, heterotopic ossification and alval; metallosis.It was also reported that the srxl acetabular cup, asrxl femoral head, and plus 2 femoral sleeve were removed.Doi: (b)(6) 2009; dor: (b)(6) 2018; right hip.
 
Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .
 
Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Asr litigation record received: litigation alleges injury, metal poisoning, emotional distress, metallosis from the metal debris, and pain.
 
Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Udi: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
ASR UNI FEMORAL IMPL SIZE 47
Type of Device
HIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's rd
leeds IN LS11 8 DT
UK  LS11 8 DT
MDR Report Key7243639
MDR Text Key99093091
Report Number1818910-2018-52804
Device Sequence Number1
Product Code KXA
Combination Product (y/n)N
PMA/PMN Number
K040627
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/06/2013
Device Catalogue Number999890247
Device Lot Number2625244
Was Device Available for Evaluation? No
Date Manufacturer Received07/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1749/1816-2011
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age77 YR
Patient Weight93
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